Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists
Sponsor study identifier
interventional
22
0 countries
N/A
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 2012
Actual (reported)May 2012
Actual (reported)August 6, 2013
Actual (reported)August 7, 2013
Actual (reported)March 12, 2014
Actual (reported)Peel Force
The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.
1 hour
The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin
An adhesive strip made of hydrocolloid adhesive
An adhesive strip made of the Strata adhesive
Tonny Karlsmark, MD
Bispebjerg Hospital, Denmark
22 participants (actual enrollment reported by the registry).
First Submitted
August 6, 2013
First Posted
August 7, 2013
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
The Influence of Baseplate Adhesive on the Degree of Leakage
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Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
March 12, 2014
Results First Posted
March 12, 2014
Record last verified: 2014-01
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Source: ClinicalTrials.gov.
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